CERTIFICATION/DISCLOSURE FORM - AdventHealth



|Please complete all of the information below and retain a copy of this form for your records. |

|*Note: Each investigator on the study, principal and sub-investigator(s), must submit a financial disclosure form |

|1. Study Name:       |

|2. Protocol number:       |

|Investigator Name:       |

|Institution Name (if applicable):       |

|5. Address:       |

|6. Telephone:       |7. Fax:       |

|8. Indicate by marking YES or NO if any of the financial interests or arrangements of concern to FDA (and described below) apply to you, your spouse, or |

|dependent children: |

| YES NO | |

| |Financial arrangements whereby the value of the compensation could be influenced by the outcome of the study. This could include, |

| |for example, compensation that is explicitly greater for a favorable outcome, or compensation to the investigator in the form of an|

| |equity interest in the sponsor or in the form of compensation tied to sales of the product, such as a royalty interest. |

| |If yes, please describe:       |

| YES NO |Significant payments of other sorts from the sponsor, excluding the costs of conducting the study or other clinical studies. This |

| |could include, for example, payments made to the investigator or the institution to support activities that have a monetary value |

| |greater than $25,000 U.S. (i.e. a grant to fund ongoing research, compensation in the form of equipment, or retainers for ongoing |

| |consultation or honoraria). |

| |If yes, please describe:       |

| YES NO |A proprietary or financial interest in the test product such as a patent, trademark, copyright, or licensing agreement. |

| |If yes, please describe:       |

| YES NO |A significant equity interest in the sponsor of the study. This would include, for example, any ownership interest, stock options,|

| |or other financial interest whose value cannot be readily determined through reference to public prices, or an equity interest in a|

| |publicly traded company exceeding $50,000 U.S. |

| |If yes, please describe:       |

|or |

| I hereby certify that none of the financial interests or arrangements listed above exist for myself, my spouse, or my dependent children. |

|In accordance with 21 CFR Parts 54.1 to 54.6, I declare that the information provided on this form is, to the best of my knowledge and belief, true, correct, |

|and complete. Furthermore, if my financial interests and arrangements, or those of my spouse and dependent children, change from the information provided above|

|during the course of the study or within one year after the last patient has completed the study as specified in the protocol, I will notify the sponsor |

|promptly. |

|9. Signature: |10. Date: |

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